Neurostimulation system for selectively estimating volume of activation and providing therapy

ABSTRACT

An external control device, neurostimulation system, and method of programming a neurostimulator. A volume of tissue activation for each of a first one or more candidate stimulation parameter sets is simulated without conveying electrical stimulation energy into the tissue. One of the first candidate stimulation parameter set(s) is selected based on each simulated volume of tissue activation. Electrical stimulation energy is conveyed into the tissue in accordance with a second one or more candidate stimulation parameter sets, wherein the initial one of the second candidate stimulation parameter set(s) is the selected one of the first candidate stimulation parameter set(s). One of the second candidate stimulation parameter set(s) is selected based on a therapeutic efficacy of the electrical stimulation energy conveyed into the tissue. The neurostimulator is programmed with the selected one of the second candidate stimulation parameter set(s).

RELATED APPLICATION DATA

The present application claims the benefit under 35 U.S.C. §119 to U.S.provisional patent application Ser. No. 61/427,441, filed Dec. 27, 2010.The foregoing application is hereby incorporated by reference into thepresent application in its entirety.

FIELD OF THE INVENTION

The present invention relates to tissue stimulation systems, and moreparticularly, to user interfaces and methods for controlling thedistribution of electrical current on segmented neurostimulation leads.

BACKGROUND OF THE INVENTION

Implantable neurostimulation systems have proven therapeutic in a widevariety of diseases and disorders. Pacemakers and Implantable CardiacDefibrillators (ICDs) have proven highly effective in the treatment of anumber of cardiac conditions (e.g., arrhythmias). Spinal CordStimulation (SCS) systems have long been accepted as a therapeuticmodality for the treatment of chronic pain syndromes, and theapplication of tissue stimulation has begun to expand to additionalapplications, such as angina pectoris and incontinence. Further, inrecent investigations, Peripheral Nerve Stimulation (PNS) systems havedemonstrated efficacy in the treatment of chronic pain syndromes andincontinence, and a number of additional applications are currentlyunder investigation.

More pertinent to the present inventions described herein, Deep BrainStimulation (DBS) has been applied therapeutically for well over adecade for the treatment of neurological disorders, includingParkinson's Disease, essential tremor, dystonia, and epilepsy, to namebut a few. Further details discussing the treatment of diseases usingDBS are disclosed in U.S. Pat. Nos. 6,845,267, 6,845,267, and 6,950,707,which are expressly incorporated herein by reference.

Each of these implantable neurostimulation systems typically includesone or more electrode carrying stimulation leads, which are implanted atthe desired stimulation site, and a neurostimulator implanted remotelyfrom the stimulation site, but coupled either directly to theneurostimulation lead(s) or indirectly to the neurostimulation lead(s)via a lead extension. The neurostimulation system may further comprise ahandheld external control device to remotely instruct theneurostimulator to generate electrical stimulation pulses in accordancewith selected stimulation parameters. Typically, the stimulationparameters programmed into the neurostimulator can be adjusted bymanipulating controls on the external control device to modify theelectrical stimulation provided by the neurostimulator system to thepatient.

Thus, in accordance with the stimulation parameters programmed by theexternal control device, electrical pulses can be delivered from theneurostimulator to the stimulation electrode(s) to stimulate or activatea volume of tissue in accordance with a set of stimulation parametersand provide the desired efficacious therapy to the patient. The beststimulus parameter set will typically be one that delivers stimulationenergy to the volume of tissue that must be stimulated in order toprovide the therapeutic benefit (e.g., treatment of movement disorders),while minimizing the volume of non-target tissue that is stimulated. Atypical stimulation parameter set may include the electrodes that areacting as anodes or cathodes, as well as the amplitude, duration, andrate of the stimulation pulses.

Significantly, non-optimal electrode placement and stimulation parameterselections may result in excessive energy consumption due to stimulationthat is set at too high an amplitude, too wide a pulse duration, or toofast a frequency; inadequate or marginalized treatment due tostimulation that is set at too low an amplitude, too narrow a pulseduration, or too slow a frequency; or stimulation of neighboring cellpopulations that may result in undesirable side effects.

For example, bilateral DBS of the subthalamic nucleus has been proven toprovide effective therapy for improving the major motor signs ofadvanced Parkinson's disease, and although the bilateral stimulation ofthe subthalamic nucleus is considered safe, an emerging concern is thepotential negative consequences that it may have on cognitivefunctioning and overall quality of life (see A. M. M. Frankemolle, etal., Reversing Cognitive-Motor Impairments in Parkinson's DiseasePatients Using a Computational Modelling Approach to Deep BrainStimulation Programming, Brain 2010; pp. 1-16). In large part, thisphenomenon is due to the small size of the subthalamic nucleus. Evenwith the electrodes are located predominately within the sensorimotorterritory, the electrical field generated by DBS is non-discriminatelyapplied to all neural elements surrounding the electrodes, therebyresulting in the spread of current to neural elements affectingcognition. As a result, diminished cognitive function during stimulationof the subthalamic nucleus may occur do to non-selective activation ofnon-motor pathways within or around the subthalamic nucleus.

The large number of electrodes available, combined with the ability togenerate a variety of complex stimulation pulses, presents a hugeselection of stimulation parameter sets to the clinician or patient. Inthe context of DBS, neurostimulation leads with a complex arrangement ofelectrodes that not only are distributed axially along the leads, butare also distributed circumferentially around the neurostimulation leadsas segmented electrodes, can be used.

To facilitate such selection, the clinician generally programs theexternal control device, and if applicable the neurostimulator, througha computerized programming system. This programming system can be aself-contained hardware/software system, or can be defined predominantlyby software running on a standard personal computer (PC). The PC orcustom hardware may actively control the characteristics of theelectrical stimulation generated by the neurostimulator to allow theoptimum stimulation parameters to be determined based on patientfeedback and to subsequently program the external control device withthe optimum stimulation parameters.

When electrical leads are implanted within the patient, the computerizedprogramming system may be used to instruct the neurostimulator to applyelectrical stimulation to test placement of the leads and/or electrodes,thereby assuring that the leads and/or electrodes are implanted ineffective locations within the patient. Once the leads are correctlypositioned, a fitting procedure, which may be referred to as anavigation session, may be performed using the computerized programmingsystem to program the external control device, and if applicable theneurostimulator, with a set of stimulation parameters that bestaddresses the neurological disorder(s).

As physicians and clinicians become more comfortable with implantingneurostimulation systems and time in the operating room decreases,post-implant programming sessions are becoming a larger portion ofprocess. Furthermore, because the body tends to adapt to the specificstimulation parameters currently programmed into a neurostimulationsystem, or the full effects of stimulation are not manifest in a shortperiod of time (i.e., not observed within a programming session),follow-up programming procedures are often needed.

For example, in the context of DBS, the brain is dynamic (e.g., due todisease progression, motor re-learning, or other changes), and a program(i.e., a set of stimulation parameters) that is useful for a period oftime may not maintain its effectiveness and/or the expectations of thepatient may increase. Further, physicians typically treat the patientwith stimulation and medication, and proper amounts of each are requiredfor optimal therapy. Thus, after the DBS system has been implanted andfitted, the patient may have to schedule another visit to the physicianin order to adjust the stimulation parameters of the DBS system if thetreatment provided by the implanted DBS system is no longer effective orotherwise is not therapeutically or operationally optimum due to, e.g.,disease progression, motor re-learning, or other changes.

Regardless of the skill of the physician or clinician, neurostimulationprogramming sessions can be especially lengthy when programmingcomplicated neurostimulation systems, such as DBS systems, where patientusually cannot feel the effects of stimulation, and the effects of thestimulation may be difficult to observe, are typically subjective, orotherwise may take a long time to become apparent. Typically, there isoften a delay between selection of the stimulation parameters at thecomputerized programming system and the delivery of the stimulation tothe patient in accordance with these parameters, mainly due to theforward and backward telemetry function between programming system andthe neurostimulator. This makes it difficult to set the stimulationparameters appropriately or otherwise select stimulation parameters thatresult in optimal treatment for the patient and/or optimal use of thestimulation resources. Clinical estimates suggest that 18-36 hours perpatient are necessary to program and assess DBS patients with currenttechniques (see Hunka K., et al., Nursing Time to Program and AssessDeep Brain Stimulators in Movement Disorder Patients, J. Neursci Nurs.37: 204-10), which is an extremely large time commitment for both thephysician/clinician and the patient.

There, thus, remains a need for a user interface that more efficientlyallows the programming of neurostimulation systems.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the present inventions, an externalcontrol device for use with a neurostimulator coupled to a plurality ofelectrodes capable of conveying electrical stimulation energy intotissue in which the electrodes are implanted is provided.

The external control device comprises output circuitry configured fortransmitting sets of stimulation parameters to the neurostimulator, anda user interface including a display device and at least a first controlelement configured to be actuated to selectively place the externalcontrol device between a first mode and a second mode. In oneembodiment, the user interface comprises at least another controlelement configured to be actuated to define the first one or morecandidate stimulation parameter sets and the second one or morecandidate stimulation parameter sets.

The external control device further comprises a processor that, when theexternal control device is in the first mode, is configured forsimulating a volume of tissue activation for each of a first pluralityof candidate stimulation parameter sets, while preventing the outputcircuitry from transmitting the first plurality of candidate stimulationparameter sets to the neurostimulator, and when the external controldevice is in the second mode, is configured for allowing the outputcircuitry to transmit a second plurality of candidate stimulationparameter sets to the neurostimulator.

In one embodiment, the user interface is configured for allowing theuser to select one of the first plurality of candidate stimulationparameter sets, and the processor is configured for automatically usingthe user selected candidate stimulation parameter set as an initial oneof the second plurality of candidate stimulation parameter sets duringthe second mode. In another embodiment, the processor is configured forscoring each simulated volume of tissue activation relative to a targettissue volume.

In an optional embodiment, the external control device further comprisesmemory configured for storing an anatomical representation (e.g., abrain model) having a target tissue volume (e.g., a subthalamicnucleus), which may be received by a user. In this case, the processor,when the external control device is in the first mode, may be configuredfor allowing the user interface to display each simulated volume oftissue activation relative to the target tissue volume on the monitor.The processor may also, when the external control device is in thesecond mode, be configured for simulating another volume of tissueactivation for each of the second plurality of candidate stimulationparameter sets, and for allowing the user interface to display eachother simulated volume of tissue activation relative to the targettissue volume. In this case, each volume of tissue activation displayedduring the first mode can be represented with a first color, and eachvolume of tissue activation displayed during the second mode can berepresented with a second color different from the first color.

In accordance with a second aspect of the present inventions, aneurostimulation system is provided. The neurostimulation systemcomprises a plurality of electrodes configured for being implantedwithin tissue, a neurostimulator coupled to the electrodes andconfigured for conveying electrical stimulation energy into the tissuevia the electrodes, and an external control device having a first modeand a second mode.

The external control device is configured for, when in a first mode,simulating a volume of tissue activation for each of a first pluralityof candidate stimulation parameter sets, while preventing theneurostimulator from conveying electrical stimulation energy, and whenin an second mode, allowing the neurostimulator to convey electricalstimulation energy in accordance with the a second plurality ofcandidate stimulation parameter sets. In one embodiment, the externalcontrol device is configured for allowing a user to enter the first oneor more candidate stimulation parameter sets and the second one or morecandidate stimulation parameter sets. In another embodiment, theexternal control device is configured for allowing the user to selectone of the first plurality of candidate stimulation parameter sets, andfor automatically using the user selected candidate stimulationparameter set as an initial one of the second plurality of candidatestimulation parameter sets during the second mode. In still anotherembodiment, the external control device is configured for scoring eachsimulated volume of tissue activation relative to a target tissuevolume.

In one preferred embodiment, the external control device is configuredfor storing an anatomical representation (e.g., a brain model) having atarget tissue volume (e.g., a subthalamic nucleus), which may bereceived from the user, and when in the first mode, displaying eachvolume of tissue activation relative to the target tissue volume. Theexternal control device, when in the second mode, may also configuredfor simulating another volume of tissue activation for each of thesecond plurality of candidate stimulation parameter sets, and displayingeach other volume of tissue activation relative to the target tissuevolume. In this case, the external control device may be configured fordisplaying an indicator that delineates the displaying of each volume oftissue activation from the displaying of each other volume of tissueactivation. For example, the indicator may be a different color for thevolume of tissue activation and the other volume of tissue activation.

In accordance with a third aspect of the present inventions, a method ofprogramming a neurostimulator coupled to a plurality of electrodes thatare implanted within the tissue of a patient is provided. The methodcomprises simulating a volume of tissue activation for each of a firstplurality of candidate stimulation parameter sets without conveyingelectrical stimulation energy into the tissue, and selecting one of thefirst plurality of candidate stimulation parameter sets based on eachsimulated volume of tissue activation. The method further comprisesconveying electrical stimulation energy into the tissue in accordancewith a second plurality of candidate stimulation parameter sets, whereinthe initial one of the second plurality of candidate stimulationparameter sets is the selected one of the first plurality of candidatestimulation parameter sets. The method further comprises selecting oneof the second plurality of candidate stimulation parameter sets based ona therapeutic efficacy of the electrical stimulation energy conveyedinto the tissue, and programming the neurostimulator with the selectedone of the second plurality of candidate stimulation parameter sets.

One method further comprises scoring each simulated volume of tissueactivation relative to a target tissue volume. In another method, eachvolume of tissue activation is displayed relative to a target tissuevolume (e.g., a subthalamic nucleus). The method may further comprisesimulating another volume of tissue activation for each of the secondplurality of candidate stimulation parameter sets, and displaying eachother volume of tissue activation relative to the target tissue volume.In this case, the method may further comprise displaying an indicatorthat delineates the displaying of each volume of tissue activation fromthe displaying of each other volume of tissue activation. For example,the indicator may be a different color for the volume of tissueactivation and the other volume of tissue activation.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is a plan view of a Deep Brain Stimulation (DBS) systemconstructed in accordance with one embodiment of the present inventions;

FIG. 2 is a profile view of an implantable pulse generator (IPG) andneurostimulation leads used in the DBS system of FIG. 1;

FIG. 3 is a cross-sectional view of a neurostimulation lead used in theDBS system of FIG. 1;

FIG. 4 is a cross-sectional view of a patient's head showing theimplantation of stimulation leads and an IPG of the DBS system of FIG.1;

FIG. 5 is front view of a remote control (RC) used in the DBS system ofFIG. 1;

FIG. 6 is a block diagram of the internal components of the RC of FIG.5;

FIG. 7 is a block diagram of the internal components of a clinician'sprogrammer (CP) used in the DBS system of FIG. 1;

FIG. 8A is a plan view of a pre-programming screen generated by the CPof FIG. 7;

FIG. 8B is a plan view of a live stimulation screen generated by the CPof FIG. 7; and

FIG. 9 is a flow diagram illustrating one method of programming the IPGof FIG. 2.

DETAILED DESCRIPTION OF THE EMBODIMENTS

At the outset, it is noted that the present invention may be used withan implantable pulse generator (IPG), radio frequency (RF) transmitter,or similar neurostimulator, that may be used as a component of numerousdifferent types of stimulation systems. The description that followsrelates to a deep brain stimulation (DBS) system. However, it is to beunderstood that the while the invention lends itself well toapplications in DBS, the invention, in its broadest aspects, may not beso limited. Rather, the invention may be used with any type ofimplantable electrical circuitry used to stimulate tissue. For example,the present invention may be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical stimulator,a spinal cord stimulator, peripheral nerve stimulator, microstimulator,or in any other neural stimulator configured to treat urinaryincontinence, sleep apnea, shoulder sublaxation, headache, etc.

Turning first to FIG. 1, an exemplary DBS neurostimulation system 10generally includes at least one implantable stimulation lead 12 (in thiscase, two), a neurostimulator in the form of an implantable pulsegenerator (IPG) 14, a remote controller RC 16, a clinician's programmer(CP) 18, an External Trial Stimulator (ETS) 20, and an external charger22.

The IPG 14 is physically connected via one or more percutaneous leadextensions 24 to the neurostimulation leads 12, which carry a pluralityof electrodes 26 arranged in an array. In the illustrated embodiment,the neurostimulation leads 12 are percutaneous leads, and to this end,the electrodes 26 may be arranged in-line along the neurostimulationleads 12. As will be described in further detail below, the IPG 14includes pulse generation circuitry that delivers electrical stimulationenergy in the form of a pulsed electrical waveform (i.e., a temporalplurality of electrical pulses) to the electrode array 26 in accordancewith a set of stimulation parameters.

The ETS 20 may also be physically connected via the percutaneous leadextensions 28 and external cable 30 to the neurostimulation leads 12.The ETS 20, which has similar pulse generation circuitry as the IPG 14,also delivers electrical stimulation energy in the form of a pulseelectrical waveform to the electrode array 26 accordance with a set ofstimulation parameters. The major difference between the ETS 20 and theIPG 14 is that the ETS 20 is a non-implantable device that is used on atrial basis after the neurostimulation leads 12 have been implanted andprior to implantation of the IPG 14, to test the responsiveness of thestimulation that is to be provided. Thus, any functions described hereinwith respect to the IPG 14 can likewise be performed with respect to theETS 20.

The RC 16 may be used to telemetrically control the ETS 20 via abi-directional RF communications link 32. Once the IPG 14 andstimulation leads 12 are implanted, the RC 16 may be used totelemetrically control the IPG 14 via a bi-directional RF communicationslink 34. Such control allows the IPG 14 to be turned on or off and to beprogrammed with different stimulation parameter sets. The IPG 14 mayalso be operated to modify the programmed stimulation parameters toactively control the characteristics of the electrical stimulationenergy output by the IPG 14. As will be described in further detailbelow, the CP 18 provides clinician detailed stimulation parameters forprogramming the IPG 14 and ETS 20 in the operating room and in follow-upsessions.

The CP 18 may perform this function by indirectly communicating with theIPG 14 or ETS 20, through the RC 16, via an IR communications link 36.Alternatively, the CP 18 may directly communicate with the IPG 14 or ETS20 via an RF communications link (not shown). The clinician detailedstimulation parameters provided by the CP 18 are also used to programthe RC 16, so that the stimulation parameters can be subsequentlymodified by operation of the RC 16 in a stand-alone mode (i.e., withoutthe assistance of the CP 18).

The external charger 22 is a portable device used to transcutaneouslycharge the IPG 14 via an inductive link 38. For purposes of brevity, thedetails of the external charger 22 will not be described herein. Detailsof exemplary embodiments of external chargers are disclosed in U.S. Pat.No. 6,895,280, which has been previously incorporated herein byreference. Once the IPG 14 has been programmed, and its power source hasbeen charged by the external charger 22 or otherwise replenished, theIPG 14 may function as programmed without the RC 16 or CP 18 beingpresent.

More significant to the present inventions, the CP 18 is capable ofstoring an anatomical representation, which in the case of DBS, will bea model of the patient's brain. The anatomical representation can beobtained from any available brain atlas, or from a patient specificbrain atlas derived from, e.g., a magnetic resonant imager (MRI),computed tomography (CT), X-ray, fluoroscopy, ventriculography,ultrasound, or any other imaging modality or a merging of any or all ofthese modalities.

The anatomical representation has a target tissue volume, thestimulation of which is known or believed to provide the needed therapyto the patient. For example, if the DBS indication is Parkinson'sdisease, the target tissue volume may be the subthalamic nucleus (STN)or the globus pallidus (GPi). If the DBS indication is Essential Tremor,the target tissue volume may be the thalamus. If the DBS indication isdepression, the target tissue volume may be one or more of the nucleusacumbens, ventral striatum, ventral capsule, anterior capsule, or theBrodmann's area 25. If the DBS indication is epilepsy, the target tissuevolume may be preferably the anterior nucleus. If the DBS indication isa gait disorder, the target tissue volume may be the pedunculopontinenucleus (PPN). If the DBS indication is dementia, Alzheimer's disease ormemory disorders, the target tissue volume may be anywhere in the Papezcircuit. Notably, the targeted tissue volumes may not be strictlyanatomical, but rather simply represent some volume of tissue that, whenstimulated, provides therapy.

The target tissue volume may be pre-defined within the anatomicalrepresentation (e.g., an anatomical structure corresponding to thetarget tissue volume may naturally provide the boundaries that delineateit from the surrounding tissue, or a graphical marking corresponding tothe target tissue volume may be incorporated into the anatomicalrepresentation prior to storing it within the CP 18) or the targettissue volume may be defined within the anatomical representation by theuser (e.g., by graphically marking the anatomical representation as itis displayed on the CP 18.

The CP 18 is configured for being placed within either a“pre-programming” mode or a “live stimulation mode.”

Advantageously, the pre-programming mode of the CP 18 allows the user totest candidate sets of stimulation parameters without actually conveyingelectrical stimulation energy to the patient, thereby obviating the needfor the time-consuming telemetric functions between the CP 18 and theIPG 14 and patient feedback regarding the efficacy of the therapy.

In particular, when in the pre-programming mode, the CP 18 is configuredfor simulating a volume of tissue activation based on each candidatestimulation parameter set and displaying each simulated volume of tissueactivation relative to the target tissue volume. The simulation oftissue volume activation can be performed in accordance with themodeling techniques referenced in Frankemolle AM, et al., ReversingCognitive-Motor Impairments in Parkinson's Disease Patients Using aComputational Modelling Approach to Deep Brain Stimulation Programming,Brain 2010, March; 133 (Pt 3): 746-61, Epub 2010 Jan. 7. In thepreferred embodiment, the CP 18 allows the user to enter the candidatestimulation parameter sets during the pre-programming mode in aconventional manner, although in other embodiments, the CP 18 mayautomatically step through pre-defined candidate stimulation parametersets with minimal or no interaction by the user.

During the pre-programming mode, the CP 18 prevents the IPG 14 fromconveying electrical stimulation energy, so that the volume of tissueactivation simulation it performed totally “off-line” without having totelemetrically communicate with the IPG 14 and without having to rely onpatient feedback. For the purposes of this specification, preventing adevice or component from performing a function may comprise eitheraffirmatively sending an instruction or control signal to that device orcomponent to not perform the function or may comprise not sending aninstruction or control signal otherwise required for the device orcomponent to perform the function.

The efficacy of the candidate stimulation parameter set or sets may bedetermined by manually (i.e., looking at the display and manuallyanalyzing the extent to which the resulting simulated volume of tissuematches the target tissue volume) or automatically by the CP 18 (e.g.,using a scoring algorithm that determines the best candidate stimulationparameter set corresponding to the simulated volume of tissue activationthat best covers the target tissue volume while minimizing the coverageof non-target tissue, which is described more fully in PCT PublicationWO 2010/065888, and is expressly incorporated herein by reference). Itcan be appreciated from this that because the user does not have to waitfor stimulation parameter sets to be communicated to the IPG 14 andpatient feedback each time the candidate stimulation parameter set ischanged, optimize or otherwise effective candidate stimulation parametersets can be identified relatively quickly.

The live stimulation mode of the CP 18 allows the user to test candidatesets of stimulation parameters in a conventional manner; i.e., byactually conveying electrical energy to the patient in accordance withthe different candidate stimulation parameter sets. However, the CP 18may utilize what was learned during the pre-programming mode to moreefficiently determine the candidate stimulation parameter set or setsthat are optimum for the therapy. In particular, when in the livestimulation mode, the CP 18 is configured for allowing the IPG 14 toconvey electrical stimulation energy in accordance with candidatestimulation parameter sets, so that they can be evaluated based onpatient feedback in a conventional manner. For the purposes of thisspecification, allowing a device or component to perform a function maycomprise either affirmatively sending an instruction or control signalto that device or component to perform the function or not sending aninstruction or control signal otherwise required to prevent the deviceor component from performing the function. In the preferred embodiment,the CP 18 allows the user to enter the candidate stimulation parametersets during the live stimulation mode in a conventional manner, althoughin other embodiments, the CP 18 may automatically step throughpre-defined candidate stimulation parameter sets with minimal or nointeraction with the user.

Advantageously, the CP 18 may select one of the candidate stimulationparameter sets tested when the CP 18 was in the pre-programming mode,and automatically use it as the initial candidate stimulation parameterset when the CP is in the live stimulation mode. Preferably, theselected candidate stimulation parameter is the optimum one obtainedeither by manual review by the user or via automatic scoring by the CP18, so that an optimum or otherwise good starting point is provided atthe beginning of the conventional programming process performed by theCP 18. It can be appreciated that by doing this, non-optimum orotherwise ineffective candidate stimulation parameter sets can bequickly eliminated when the CP 18 is operated in the pre-programmingmode, whereas in the prior art, such non-optimum or ineffectivecandidate stimulation parameters are tediously eliminated during theconventional programming process.

In an optional embodiment, concurrent with allowing the IPG 14 to conveyelectrical stimulation energy, the CP 18, when in the live stimulationmode, is configured for simulating a volume of tissue activation basedon each candidate stimulation parameter set and displaying eachsimulated volume of tissue activation relative to the target tissuevolume. In this case, the CP 18 may provide an indication thatdelineates the pre-programming mode from the live stimulation mode,e.g., by using labels on the display and/or representing the simulatedvolume of tissue for the different modes with different colors.

Having generally described the neurostimulation system 10, the featuresof the neurostimulation system 10 will now be described in furtherdetail.

Referring to FIG. 2, the IPG 14 comprises an outer case 40 for housingthe electronic and other components (described in further detail below),and a connector 42 to which the proximal end of the neurostimulationlead 12 mates in a manner that electrically couples the electrodes 26 tothe internal electronics (described in further detail below) within theouter case 40. The outer case 40 is composed of an electricallyconductive, biocompatible material, such as titanium, and forms ahermetically sealed compartment wherein the internal electronics areprotected from the body tissue and fluids. In some cases, the outer case40 may serve as an electrode.

Each of the neurostimulation leads 12 comprises an elongated cylindricallead body 43, and the electrodes 26 take the form of segmentedelectrodes that are circumferentially and axially disposed about thelead body 43. By way of non-limiting example, and with further referenceto FIG. 3, each neurostimulation lead 12 may carry sixteen electrodes,arranged as four rings of electrodes (the first ring consisting ofelectrodes E1-E4; the second ring consisting of electrodes E5-E8; thethird ring consisting of electrodes E9-E12; and the fourth ringconsisting of E13-E16) or four axial columns of electrodes (the firstcolumn consisting of electrodes E1, E5, E9, and E13; the second columnconsisting of electrodes E2, E6, E10, and E14; the third columnconsisting of electrodes E3, E7, E11, and E15; and the fourth columnconsisting of electrodes E4, E8, E12, and E16). The actual number andshape of leads and electrodes will, of course, vary according to theintended application. Further details describing the construction andmethod of manufacturing percutaneous stimulation leads are disclosed inU.S. patent application Ser. No. 11/689,918, entitled “Lead Assembly andMethod of Making Same,” and U.S. patent application Ser. No. 11/565,547,entitled “Cylindrical Multi-Contact Electrode Lead for NeuralStimulation and Method of Making Same,” the disclosures of which areexpressly incorporated herein by reference.

As will be described in further detail below, the IPG 14 includes abattery and pulse generation circuitry that delivers the electricalstimulation energy in the form of a pulsed electrical waveform to theelectrode array 26 in accordance with a set of stimulation parametersprogrammed into the IPG 14. Such stimulation parameters may compriseelectrode combinations, which define the electrodes that are activatedas anodes (positive), cathodes (negative), and turned off (zero),percentage of stimulation energy assigned to each electrode(fractionalized electrode configurations), and electrical pulseparameters, which define the pulse amplitude (measured in milliamps orvolts depending on whether the IPG 14 supplies constant current orconstant voltage to the electrode array 26), pulse duration (measured inmicroseconds), pulse rate (measured in pulses per second), and burstrate (measured as the stimulation on duration X and stimulation offduration Y).

Electrical stimulation will occur between two (or more) activatedelectrodes, one of which may be the IPG case. Simulation energy may betransmitted to the tissue in a monopolar or multipolar (e.g., bipolar,tripolar, etc.) fashion. Monopolar stimulation occurs when a selectedone of the lead electrodes 26 is activated along with the case of theIPG 14, so that stimulation energy is transmitted between the selectedelectrode 26 and case. Bipolar stimulation occurs when two of the leadelectrodes 26 are activated as anode and cathode, so that stimulationenergy is transmitted between the selected electrodes 26. Tripolarstimulation occurs when three of the lead electrodes 26 are activated,two as anodes and the remaining one as a cathode, or two as cathodes andthe remaining one as an anode.

In the illustrated embodiment, IPG 14 can individually control themagnitude of electrical current flowing through each of the electrodes.In this case, it is preferred to have a current generator, whereinindividual current-regulated amplitudes from independent current sourcesfor each electrode may be selectively generated. Although this system isoptimal to take advantage of the invention, other stimulators that maybe used with the invention include stimulators having voltage regulatedoutputs. While individually programmable electrode amplitudes areoptimal to achieve fine control, a single output source switched acrosselectrodes may also be used, although with less fine control inprogramming. Mixed current and voltage regulated devices may also beused with the invention. Further details discussing the detailedstructure and function of IPGs are described more fully in U.S. Pat.Nos. 6,516,227 and 6,993,384, which are expressly incorporated herein byreference.

As shown in FIG. 4, two percutaneous neurostimulation leads 12 may beintroduced through a burr hole 46 (or alternatively, two respective burrholes) formed in the cranium 48 of a patient 44, and introduced into theparenchyma of the brain 49 of the patient 44 in a conventional manner,such that the electrodes 26 are adjacent a target tissue region, thestimulation of which will treat the dysfunction (e.g., the ventrolateralthalamus, internal segment of globus pallidus, substantia nigra parsreticulate, subthalamic nucleus, or external segment of globuspallidus). Thus, stimulation energy can be conveyed from the electrodes26 to the target tissue region to change the status of the dysfunction.Due to the lack of space near the location where the neurostimulationleads 12 exit the burr hole 46, the IPG 14 is generally implanted in asurgically-made pocket either in the chest, or in the abdomen. The IPG14 may, of course, also be implanted in other locations of the patient'sbody. The lead extension(s) 24 facilitates locating the IPG 14 away fromthe exit point of the neurostimulation leads 12.

Referring now to FIG. 5, one exemplary embodiment of an RC 16 will nowbe described. As previously discussed, the RC 16 is capable ofcommunicating with the IPG 14, CP 18, or ETS 20. The RC 16 comprises acasing 50, which houses internal componentry (including a printedcircuit board (PCB)), and a lighted display device 52 and button pad 54carried by the exterior of the casing 50. In the illustrated embodiment,the display device 52 is a lighted flat panel display device, and thebutton pad 54 comprises a membrane switch with metal domes positionedover a flex circuit, and a keypad connector connected directly to a PCB.In an optional embodiment, the display device 52 has touchscreencapabilities. The button pad 54 includes a multitude of buttons 56, 58,60, and 62, which allow the IPG 14 to be turned ON and OFF, provide forthe adjustment or setting of stimulation parameters within the IPG 14,and provide for selection between screens.

In the illustrated embodiment, the button 56 serves as an ON/OFF buttonthat can be actuated to turn the IPG 14 ON and OFF. The button 58 servesas a select button that allows the RC 16 to switch between screendisplays and/or parameters. The buttons 60 and 62 serve as up/downbuttons that can actuated to increment or decrement any of stimulationparameters of the pulse generated by the IPG 14, including pulseamplitude, pulse width, and pulse rate. For example, the selectionbutton 58 can be actuated to place the RC 16 in an “Pulse AmplitudeAdjustment Mode,” during which the pulse amplitude can be adjusted viathe up/down buttons 60, 62, a “Pulse Width Adjustment Mode,” duringwhich the pulse width can be adjusted via the up/down buttons 60, 62,and a “Pulse Rate Adjustment Mode,” during which the pulse rate can beadjusted via the up/down buttons 60, 62. Alternatively, dedicatedup/down buttons can be provided for each stimulation parameter. Ratherthan using up/down buttons, any other type of actuator, such as a dial,slider bar, or keypad, can be used to increment or decrement thestimulation parameters. Further details of the functionality andinternal componentry of the RC 16 are disclosed in U.S. Pat. No.6,895,280, which has previously been incorporated herein by reference.

Referring to FIG. 6, the internal components of an exemplary RC 16 willnow be described. The RC 16 generally includes a processor 64 (e.g., amicrocontroller), memory 66 that stores an operating program forexecution by the processor 64, as well as stimulation parameter sets ina look-up table (described below), input/output circuitry, and inparticular, telemetry circuitry 68 for outputting stimulation parametersto the IPG 14 and receiving status information from the IPG 14, andinput/output circuitry 70 for receiving stimulation control signals fromthe button pad 54 and transmitting status information to the displaydevice 52 (shown in FIG. 5). As well as controlling other functions ofthe RC 16, which will not be described herein for purposes of brevity,the processor 64 generates new stimulation parameter sets in response tothe user operation of the button pad 54. These new stimulation parametersets would then be transmitted to the IPG 14 via the telemetry circuitry68. Further details of the functionality and internal componentry of theRC 16 are disclosed in U.S. Pat. No. 6,895,280, which has previouslybeen incorporated herein by reference.

As briefly discussed above, the CP 18 greatly simplifies the programmingof multiple electrode combinations, allowing the physician or clinicianto readily determine the desired stimulation parameters to be programmedinto the IPG 14, as well as the RC 16. Thus, modification of thestimulation parameters in the programmable memory of the IPG 14 afterimplantation is performed by a clinician using the CP 18, which candirectly communicate with the IPG 14 or indirectly communicate with theIPG 14 via the RC 16. That is, the CP 18 can be used by the physician orclinician to modify operating parameters of the electrode array 26 inthe brain.

The overall appearance of the CP 18 is that of a laptop personalcomputer (PC), and in fact, may be implanted using a PC that has beenappropriately configured to include a directional-programming device andprogrammed to perform the functions described herein. Alternatively, theCP 18 may take the form of a mini-computer, personal digital assistant(PDA), etc., or even a remote control (RC) with expanded functionality.Thus, the programming methodologies can be performed by executingsoftware instructions contained within the CP 18. Alternatively, suchprogramming methodologies can be performed using firmware or hardware.In any event, the CP 18 may actively control the characteristics of theelectrical stimulation generated by the IPG 14 to allow the optimumstimulation parameters to be determined based on patient response andfeedback and for subsequently programming the IPG 14 with the optimumstimulation parameters.

Referring to FIG. 7, to allow the user to perform these functions, theCP 18 includes a standard user input device 72 (e.g., a keyboard, mouse,joystick, etc.) to allow a clinician to input information and controlthe process and a display device 76 housed in a case. In the illustratedembodiment, the monitor 76 is a conventional screen. Alternatively,instead of being conventional, the monitor 76 may be a digitizer screen,such as touchscreen (not shown), and may be used in conjunction with anactive or passive digitizer stylus/finger touch.

The CP 18 generally includes a processor 80 (e.g., a central processorunit (CPU)) and memory 82 that stores a stimulation programming package84, which can be executed by the processor 80 to allow the user toprogram the IPG 14, and RC 16. The memory 82 also stores the anatomicalrepresentation, and in this case, a representation of the brain, asdescribed above. The CP 18 further includes output circuitry 86 (e.g.,via the telemetry circuitry of the RC 16) for downloading stimulationparameters to the IPG 14 and RC 16 and for uploading stimulationparameters already stored in the memory 66 of the RC 16, via thetelemetry circuitry 68 of the RC 16.

Execution of the programming package 84 by the processor 80 provides amultitude of display devices (not shown) that can be navigated throughvia the user input device 72. These display devices allow the clinicianto, among other functions, to select or enter patient profileinformation (e.g., name, birth date, patient identification, physician,diagnosis, and address), enter procedure information (e.g.,programming/follow-up, implant trial system, implant IPG, implant IPGand lead(s), replace IPG, replace IPG and leads, replace or reviseleads, explant, etc.), generate a pain map of the patient, define theconfiguration and orientation of the leads, initiate and control theelectrical stimulation energy output by the leads 12, and select andprogram the IPG 14 with stimulation parameters in both a surgicalsetting and a clinical setting. Further details discussing theabove-described CP functions are disclosed in U.S. patent applicationSer. No. 12/501,282, entitled “System and Method for Converting TissueStimulation Programs in a Format Usable by an Electrical CurrentSteering Navigator,” and U.S. patent application Ser. No. 12/614,942,entitled “System and Method for Determining Appropriate Steering Tablesfor Distributing Stimulation Energy Among Multiple NeurostimulationElectrodes,” which are expressly incorporated herein by reference.

Most pertinent to the present inventions, execution of the programmingpackage 84 provides a user interface that allows the CP 18 to beoperated in the previously described pre-programming mode andprogramming mode, during which a simulated or actual electricalstimulation field conveyed by selected ones of the electrodes 26 can bemodified, e.g., by axially, circumferentially, and/or radiallydisplacing the locus of the stimulation field circumferentially relativeto a single neurostimulation lead 12 or both neurostimulation leads 12,and axially and/or circumferentially expanding or contracting theelectrical stimulation field about its locus. Further details discussingvarious methods that can be used to modify an electrical stimulationfield are described in U.S. Provisional Patent Application Ser. No.61/374,465, entitled “User Interface for Segmented NeurostimulationLeads.

Referring to FIGS. 8 a and 8 b, a pre-programming screen 100′ and a livestimulation screen 100″ (collectively, the programming screens 100)allowing a user to perform stimulation parameter testing can begenerated by the CP 18. In the illustrated embodiment, various controlelements displayed on the programming screen 100 are implemented asgraphical icons that can be clicked with a mouse or touched with afinger in the case of a touchscreen. Alternatively, any of the controlelements described herein may be implemented as mechanical buttons,keys, sliders, etc. that can be pressed or otherwise moved to actuatethe control elements.

The programming screen 100 includes various stimulation parametercontrols that can be operated by the user to manually adjust orotherwise define stimulation parameters. Such stimulation parameteradjustment can be performed in any one or more of a variety of manners,e.g., using look-up tables, formulas, or algorithms, as is known in theprior art.

In particular, the programming screen 100 includes a pulse widthadjustment control 104 (expressed in microseconds (ps)), a pulse rateadjustment control 106 (expressed in pulses per second (pps), and apulse amplitude adjustment control 108 (expressed in milliamperes (mA)).Each control includes a first arrow that can be clicked to decrease thevalue of the respective stimulation parameter and a second arrow thatcan be clicked to increase the value of the respective stimulationparameter. The programming screen 100 also includes multipolar/monopolarstimulation selection control 110, which includes check boxes that canbe alternately clicked by the user to provide multipolar or monopolarstimulation. In an optional embodiment, the case 40 of the IPG 14 may betreated as one of the lead electrodes 26, such that both the caseelectrode 40 and at least one of the lead electrodes 26 can be used toconvey anodic electrical current at the same time.

The programming screen 100 also includes an electrode combinationcontrol 112 having arrows that can be clicked by the user to select oneof three different electrode combinations 1-4. Each of the electrodecombinations 1-4 can be created using a variety of control elements.

The programming screen 100 also includes a mode selection controlelement 114 and two sets of electrical stimulation field modificationcontrol elements—a set of axial modification control elements 116 and aset of circumferential modification control elements 118. When the modeselection control element 114 is actuated, the processor 80 isconfigured for selectively placing the field modification controlelements in either an electrical stimulation field displacement mode,during which the processor 80 generates stimulation parameter setsdesigned to axially and/or circumferentially displace the locus of theelectrical stimulation field relative to the axis of the lead(s) 12 uponactuation of one of the arrow control elements 116 a, 116 b or one ofthe arrow control elements 118 a, 118 b, or in an electrical fieldstimulation field shaping mode, during which the processor 80 generatesstimulation parameter sets designed to axially or circumferentiallyexpand/contract electrical stimulation field relative to the axis of thelead(s) 12 upon actuation of one of the arrow control elements 116 a,116 b or one of the arrow control elements 118 a, 118 b.

In the illustrated embodiment, the mode selection control element 114includes check boxes that can be alternately clicked by the user toselectively place the field modification control elements between theelectrical stimulation field displacement mode and the electricalstimulation field shaping mode. Alternatively, the mode selectioncontrol element 114 takes the form of a button that can be repeatedlyclicked to toggle the field modification control elements 116, 118between the modes. Optionally, a set of radial modification controlelements (not shown) can be provided. Further details discussing theillustrated control elements of programming screen 100, as well as othercontrol elements for varying the electrical stimulation field, aredescribed in U.S. Provisional Patent Application Ser. No. 61/374,879,which was previously incorporated herein by reference.

Significantly, the programming screen 100 includes a programming modecontrol element 120 that allows a user to selectively place the CP 18 ineither the pre-programming mode or the live stimulation mode. In theillustrated embodiment, actuation of the programming mode controlelement 120 toggles the CP 18 between the pre-programming mode and thelive stimulation mode. In alternative embodiments, separate controlelements (not shown) can be respectively provided for thepre-programming mode and the live stimulation mode.

The processor 80 is configured for instructing the display device 76 todisplay three-dimensional graphical renderings of the lead 12′ andelectrodes 26′ relative to the anatomical representation 200, which inthis case, is a model of a brain having a target tissue volume 202, andin particular, the STN.

When the CP 18 is in the pre-programming mode (FIG. 8 a), the processor80 is configured for simulating a volume of tissue activation 204′ foreach of the candidate stimulation parameter sets generated in responseto actuation of any of the field modification control elements 116, 118,and instructing the display device 76 to display, on the pre-programmingscreen 100′, the simulated volume of tissue activation 204′ relative tothe anatomical representation 200, while preventing the output circuitry86 from transmitting the candidate stimulation parameter sets to the IPG14. In the preferred embodiment, the volume of tissue activation 204′ issuperimposed over the anatomical representation 200. In the illustratedembodiment, although the graphical lead 12, anatomical representation200, and volume of tissue activation 204′ are displayed in an obliqueview, they can be alternatively displayed in any one or more oftraditional planes of section (e.g., axial, coronal, and sagittal).

When the CP 18 is in the live stimulation mode (FIG. 8 b), the processor80 is configured for instructing the output circuitry 86 to transmitcandidate stimulation parameter sets generated in response to actuationof any of the field modification control elements 116, 118 to the IPG14. In an optional embodiment, concurrently with the transmission of thecandidate stimulation parameter sets to the IPG 14, the processor 80 isconfigured for simulating a volume of tissue activation 204″ for each ofthe candidate stimulation parameter sets generated in response toactuation of any of the field modification control elements 116, 118,and instructing the display device 76 to display, on the livestimulation screen 100″, the simulated volume of tissue activation 204″relative to the anatomical representation 200, in the manner describedabove with respect to the pre-programming mode.

In the illustrated embodiment, an indicator is used to distinguish whenthe CP 18 is in the pre-programming mode (when no stimulation energy isconveyed from the IPG 14) and when the CP 18 is in the live stimulationmode (when stimulation is conveyed from the IPG 14). In the illustratedembodiment, the pre-programming screen 100′ (FIG. 8 a) has a textualindication “pre-programming mode,” and the live stimulation screen 100″(FIG. 8 b) has a textual indication “live stimulation mode.” The colorsof the simulated volumes of tissue 204 displayed in the respectiveprogramming screens 100′ and 100″ may also be different. For example,the color of the simulated volume of tissue 204′ displayed in thepre-programming screen 100′ may be a grey color and the color of thesimulated volume of tissue 204″ displayed in the live stimulation screen100″ may be a green color.

The CP 18 allows the user to select one of the candidate stimulationparameter sets tested during the pre-programming mode to be used duringoperation in the live stimulation mode. In the illustrated embodiment,when the programming mode control element 120 is actuated to transitionthe CP 18 from the pre-programming mode to the live stimulation mode,the processor 80 uses the last candidate parameter set tested in thepre-programming mode as the initial candidate stimulation parameter settested during the live stimulation mode. In an alternative embodiment,the CP 18 allows the user to select any candidate stimulation parametertested during the pre-programming mode to be used as the initialcandidate stimulation parameter set tested during the live stimulationmode. For each candidate stimulation parameter set tested during thepre-programming mode, the processor 80 may score the simulated volume oftissue activation 204′ relative to the target tissue volume 202, andeither the user may select one of the candidate stimulation parametersets based on the scores (e.g., the candidate stimulation parameter setcorresponding to the highest score) for use as the initial candidatestimulation parameter set during the live stimulation mode, or theprocessor 80 may automatically select the candidate stimulationparameter set based on the scores.

Having described the arrangement and function of the components withinthe neurostimulation system 10, one method of programming the IPG 14will now be described with respect to FIG. 9.

First, if the CP 18 is not already in the pre-programming mode, the useractuates the mode selection control element 120 to place the CP 18 inthe pre-programming mode (step 150). Then, the user serially selects aplurality of candidate stimulation parameter sets to be tested byrepeatedly actuating the electrical stimulation field modificationelements 116, 118 (step 152). The CP 18 simulates a volume of tissueactivation for each of these candidate stimulation parameter setswithout conveying electrical stimulation energy from the IPG 14 (step154), and displays each simulated volume of tissue activation relativeto the target tissue volume (in this case, the STN) (step 156). Then,one of the tested candidate stimulation parameter sets is selected basedon each simulated volume of tissue activation (step 158). For example,the user may look at each simulated volume of tissue activationdisplayed relative to the target tissue volume, and determine based onthat, which one of the tested candidate stimulation parameter sets isthe most effective. Or the CP 18 may score each simulated volume oftissue relative to the target tissue volume, and select the testedcandidate stimulation parameter set corresponding to the highest score.

Next, the user actuates the mode selection control element 120 to placethe CP 18 in the live stimulation mode (step 160). Using the selectedcandidate stimulation parameter set as an initial candidate stimulationparameter set, electrical stimulation energy is conveyed into the tissueserially in accordance with a respective second plurality of candidatestimulation parameter sets (step 162). An optional method may furthercomprise simulating another volume of tissue activation for each of thesecond plurality of candidate stimulation parameter sets (step 164), anddisplaying each other volume of tissue activation relative to the targettissue volume (step 166). In a conventional manner, one of the secondplurality of candidate stimulation parameter sets can be selected basedon a therapeutic efficacy of the electrical stimulation energy conveyedinto the tissue (e.g., based on patient feedback) (step 168). Theselected candidate stimulation parameter set can then be programmed intonon-volatile memory in the IPG 14 for subsequent selection by the user(step 170). If need be, the process can then be repeated to program theIPG 14 with another candidate stimulation parameter set.

Although the foregoing techniques have been described as beingimplemented in the CP 16, it should be noted that this technique may bealternatively or additionally implemented in the RC 14.

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

What is claimed is:
 1. An external control device for use with aneurostimulator coupled to a plurality of electrodes capable ofconveying electrical stimulation energy into tissue in which theelectrodes are implanted, comprising: output circuitry configured forcommunicating with the neurostimulator; a user interface including adisplay device and at least a first control element configured to beactuated to selectively place the external control device between afirst mode and a second mode, and at least a second control elementconfigured to be actuated to define a plurality of different candidateelectrode combinations; and a processor, when the external controldevice is in the first mode, configured for simulating a volume oftissue activation based on each of a first one or more candidateelectrode combinations, while preventing the output circuitry fromtransmitting the first one or more of candidate electrode combinationsto the neurostimulator in response to the definition of each of thefirst one or more electrode combinations, and when the external controldevice is in the second mode, configured for allowing the outputcircuitry to transmit a second one or more of candidate electrodecombinations to the neurostimulator.
 2. The external control device ofclaim 1, wherein the first one or more candidate electrode combinationscomprises a plurality of candidate electrode combinations, wherein theuser interface is configured for allowing the user to select one of theplurality of candidate electrode combinations, and wherein the processoris configured for automatically using the user selected candidateelectrode combination as an initial one of the second one or morecandidate electrode combinations during the second mode.
 3. The externalcontrol device of claim 1, wherein the processor is configured forscoring each simulated volume of tissue activation relative to a targettissue volume.
 4. The external control device of claim 1, furthercomprising memory configured for storing an anatomical representationhaving a target tissue volume, wherein the processor, when the externalcontrol device is in the first mode, is configured for allowing the userinterface to display each simulated volume of tissue activation relativeto the target tissue volume on the monitor.
 5. The external controldevice of claim 4, wherein the processor, when the external controldevice is in the second mode, is configured for simulating anothervolume of tissue activation for each of the second one or more candidateelectrode combinations, and for allowing the user interface to displayeach other simulated volume of tissue activation relative to the targettissue volume.
 6. The external control device of claim 5, wherein eachvolume of tissue activation is represented with a first color, and eachother volume of tissue activation is represented with a second colordifferent from the first color.
 7. The external control device of claim4, wherein the user interface is configured for receiving the anatomicalrepresentation from a user.
 8. The external control device of claim 4,wherein the anatomical representation is a brain model.
 9. The externalcontrol device of claim 8, wherein the target tissue volume is asubthalamic nucleus.
 10. The external control device of claim 1, furthercomprising a housing containing the output circuitry, user interface,and processor.
 11. The external control device of claim 1, wherein theplurality of different candidate electrode combinations comprises aplurality of different candidate fractionalized electrode combinations.12. A neurostimulation system, comprising: a plurality of electrodesconfigured for being implanted within tissue; a neurostimulator coupledto the electrodes and configured for conveying electrical stimulationenergy into the tissue via the electrodes; and an external controldevice configured for allowing a user to enter a first one or morecandidate electrode combinations and a second one or more candidateelectrode combinations, the external control device having a first modeand a second mode, the external control device configured for, when in afirst mode, simulating a volume of tissue activation based on each ofthe first one or more candidate electrode combinations, while preventingthe neurostimulator from conveying electrical stimulation energy inresponse to the user entry of each of the first one or more candidateelectrode combinations, and when in an second mode, allowing theneurostimulator to convey electrical stimulation energy in accordancewith the second one or more candidate electrode combinations.
 13. Theneurostimulation system of claim 12, wherein the first one or morecandidate electrode combinations comprises a plurality of candidateelectrode combinations, wherein the external control device isconfigured for allowing the user to select one of the plurality ofcandidate electrode combinations, and for automatically using the userselected candidate electrode combination set as an initial one of thesecond one or more candidate electrode combinations during the secondmode.
 14. The neurostimulation system of claim 12, wherein the externalcontrol device is configured for scoring each simulated volume of tissueactivation relative to a target tissue volume.
 15. The neurostimulationsystem of claim 12, wherein the external control device is configuredfor storing an anatomical representation having a target tissue volume,and when in the first mode, displaying each volume of tissue activationrelative to the target tissue volume.
 16. The neurostimulation system ofclaim 15, wherein the external control device, when in the second mode,is configured for simulating another volume of tissue activation foreach of the second one or more candidate electrode combinations, anddisplaying each other volume of tissue activation relative to the targettissue volume.
 17. The neurostimulation system of claim 16, wherein theexternal control device is configured for displaying an indicator thatdelineates the displaying of each volume of tissue activation from thedisplaying of each other volume of tissue activation.
 18. Theneurostimulation system of claim 17, wherein the indicator is adifferent color for the volume of tissue activation and the other volumeof tissue activation.
 19. The neurostimulation system of claim 15,wherein the external control device is configured for receiving theanatomical representation from a user.
 20. The neurostimulation systemof claim 15, wherein the anatomical representation is a brain model. 21.The neurostimulation system of claim 20, wherein the target tissuevolume is a subthalamic nucleus.
 22. The neurostimulation system ofclaim 12, wherein the first one or more candidate electrode combinationsand the second one or more candidate electrode combinations arefractionalized electrode combinations.
 23. A method of programming aneurostimulator coupled to a plurality of electrodes that are implantedwithin the tissue of a patient, comprising: simulating a volume oftissue activation based on each of a first plurality of candidateelectrode combinations without conveying electrical stimulation energyinto the tissue; selecting one of the first plurality of candidateelectrode combinations based on each simulated volume of tissueactivation; conveying electrical stimulation energy into the tissue inaccordance with a second one or more candidate electrode combinations,wherein the initial one of the second one or more candidate electrodecombinations is the selected one of the first plurality of candidateelectrode combinations; selecting one of the second one or morecandidate electrode combinations based on a therapeutic efficacy of theelectrical stimulation energy conveyed into the tissue; and programmingthe neurostimulator with the selected one of the second one or morecandidate electrode combinations.
 24. The method of claim 23, furthercomprising scoring each simulated volume of tissue activation relativeto a target tissue volume.
 25. The method of claim 23, wherein eachvolume of tissue activation is displayed relative to a target tissuevolume.
 26. The method of claim 25, further comprising simulatinganother volume of tissue activation for each of the second one or morecandidate electrode combinations, and displaying each other volume oftissue activation relative to the target tissue volume.
 27. The methodof claim 26, further comprising displaying an indicator that delineatesthe displaying of each volume of tissue activation from the displayingof each other volume of tissue activation.
 28. The method of claim 27,wherein the indicator is a different color for the volume of tissueactivation and the other volume of tissue activation.
 29. The method ofclaim 25, wherein the target tissue volume is a subthalamic nucleus. 30.The method of claim 23, wherein the first plurality of candidateelectrode combinations and the second one or more electrode combinationsare fractionalized electrode combinations.